Copolymer compositions for oral delivery

Abstract

Compositions for oral delivery having a biological agent or protein, peptide, or derivative thereof, and a poly(oxyethylene)-poly(oxypropylene) block copolymer. The compositions are useful in oral delivery of numerous agents. The invention also encompasses methods of treatment using the same.

What is claimed is:  
     
       1. A method of treating a mammal comprising administering to said mammal an effective amount of a composition for the delivery of biologically active agents comprising a mixture of poly(oxyethylene)-poly(oxypropylene) block copolymers and at least one biologically active agent, and wherein the mixture comprises at least one block copolymer with ethylene(oxide) content of 50% or less, and at least one block copolymer with ethylene(oxide) content of 50% or more. 
     
     
       2. The method according to  claim 1 , wherein said block copolymer is of the formula:                    
       in which x, y, z, i, and j have values from about 2 to about 800, and wherein for each R 1 , R 2  pair, one is hydrogen and the other is a methyl group.  
     
     
       3. The method according to  claim 1  wherein said block copolymer is of the formula:                    
       wherein for each R 1 , R 2  pair, one is hydrogen and the other is a methyl group, and the ethylene(oxide) content of said block copolymer is less than 50%.  
     
     
       4. The method according to  claim 1 , wherein the biologically active agent is selected from the group consisting of immunomodulators, cytokines, hormones, enzymes, tissue plasminogen activators, clotting factors, colony stimulating factors, and erythropoietins. 
     
     
       5. The method according to  claim 4  wherein the hormone is a human growth hormone. 
     
     
       6. The method according to  claim 5  wherein the hormone is insulin. 
     
     
       7. The method according to  claim 1  wherein the biologically active agent is a neuropeptide, or derivative thereof. 
     
     
       8. The method according to  claim 1  wherein the biologically active agent is selected from the group consisting of recombinant soluble receptors and monoclonal antibodies. 
     
     
       9. The method according to  claim 1 , wherein the ratio by weight of the block copolymer with ethylene(oxide) content of 50% or less to the block copolymer with ethylene(oxide) content of 50% or more is 1:2. 
     
     
       10. The method according to  claim 1 , wherein the ratio by weight of the block copolymer with ethylene(oxide) content of 50% or less to the block copolymer with ethylene(oxide) content of 50% or more is 1:5.